Philippine Neurological Association One Database - Stroke

Ischemic Stroke Clinical Trial

— PNA1DB-Stroke  

Official title:

Philippine Neurological Association One Database - Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972058
• Other study ID #: PNA1DB-Stroke
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Philippine Neurological Association
• Contact: Oliber Biaro
• Phone: +63 8723 2102
• Email: philneuro.research[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients hospitalized for transient ischemic attack (TIA) or stroke in the 11 accredited adult neurology training institutions in the Philippines. Data will be collected from each patient while admitted in the hospital and until hospital discharge. Data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed.

Description:

Primary objective is to prospectively collect data on demographics, medical history, in-hospital management, and outcomes among patients with first or recurrent TIA or ischemic or hemorrhagic stroke admitted in accredited adult neurology training institutions in the Philippines.

Secondary objectives are:

1. To determine the in-patient case load of first and recurrent TIA and stroke.

2. To determine the profile of patients admitted for first or recurrent TIA or stroke.

3. To determine the types of diagnostic and therapeutic management received by patients with first or recurrent TIA or stroke.

4. To determine the outcomes of patients with first or recurrent TIA or stroke at the time of hospital discharge.

5. To evaluate factors that predict outcome among patients with first or recurrent TIA or stroke.

6. To assess and audit the overall quality of care received by patients admitted for first or recurrent TIA or stroke.

7. To perform other future analyses, sanctioned by the Philippine Neurological Association (PNA), that may improve knowledge on the care of patients with first and/or recurrent TIA or stroke.

All eligible patients will be assigned a study identification (ID) number and included in the site log kept confidentially in each site. Corresponding anonymized data on demographics, medical history, stroke sub-type, in-hospital management and discharge outcomes will be collected from each patient and entered in the database using a secure online data collection tool.

Collective data will be extracted, summarized, and analyzed for the secondary objectives every year with oversight provided by the Philippine Neurological Association.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)

2. 18 years old or older

3. Admitted in the participating hospital

4. If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative

Exclusion Criteria:

1. Patients with previous TIA or stroke who are admitted to the hospital for medical conditions other than an acute stroke, e.g., patient with non-acute stroke admitted for pneumonia, rehabilitation, or procedures, such as gastric tube insertion, etc.

2. Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Venous Thrombosis
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Subarachnoid Hemorrhage
• Thrombosis
• Transient Ischemic Attack
• Venous Thrombosis

Locations

Country	Name	City	State
Philippines	Baguio General Hospital and Medical Center	Baguio City	Benguet
Philippines	Chong Hua Hospital	Cebu City
Philippines	Makati Medical Center	Makati City
Philippines	Jose R. Reyes Memorial Medical Center	Manila
Philippines	University of Santo Tomas Hospital	Manila
Philippines	University of the Philippines - Philippine General Hospital	Manila
Philippines	The Medical City	Pasig City
Philippines	East Avenue Medical Center	Quezon City
Philippines	Quirino Memorial Medical Center	Quezon City
Philippines	St. Luke's Medical Center (QC, BGC)	Quezon City
Philippines	University of the East - Ramon Magsaysay Memorial Medical Center	Quezon City

Sponsors (1)

Lead Sponsor	Collaborator
Philippine Neurological Association

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital caseload	Number of TIA and stroke cases admitted in participating sites.	3 years
Secondary	In-hospital diagnostic procedure (brain scan)	Rate of performance of brain scan.	From admission to discharge, may be up to 1 month
Secondary	In-hospital diagnostic procedures (electrocardiogram)	Rate of performance of electrocardiogram.	From admission to discharge, may be up to 1 month
Secondary	In-hospital diagnostic procedures (echocardiogram)	Rate of performance of echocardiogram.	From admission to discharge, may be up to 1 month
Secondary	In-hospital diagnostic procedures (cerebral vascular studies)	Rate of performance of any cerebral vascular study.	From admission to discharge, may be up to 1 month
Secondary	In-hospital therapeutic management (thrombolysis)	Rate of treatment with thrombolysis (intravenous and/or endovascular).	From admission to discharge, may be up to 1 month
Secondary	In-hospital therapeutic management (anti-thrombotics)	Rate of treatment with any anti-thrombotic (anti-platelet and/or anti-coagulant).	From admission to discharge, may be up to 1 month
Secondary	In-hospital therapeutic management (rehabilitation)	Rate of rehabilitation (physical therapy and/or occupational therapy and or speech therapy).	From admission to discharge, may be up to 1 month
Secondary	In-hospital complications from TIA or stroke	Rate of complications arising from TIA or stroke.	From admission to discharge, may be up to 1 month
Secondary	Vital status at hospital discharge	Alive or dead	At discharge, may be up to 1 month
Secondary	Functional status at hospital discharge	modified Rankin Scale	At discharge, may be up to 1 month
Secondary	Neurological status at hospital discharge	National Institute of Health Stroke Scale	At discharge, may be up to 1 month